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Based on review of Governing Board Bylaws, meeting minutes, Medical Staff Bylaws, quality reports, policy and procedures, and staff interviews it was determined that the Governing Body failed to: 1.) ensure that patient's rights were protected 2.) ensure that an effective quality assessment and performance improvement program (QAPI) was implemented, and 3.) ensure that the ME's office was notified of deaths as required when one (P#1) of five (P#1, P#2, P#3, P#4, P#5) patients reviewed suffered the demise of her full-term infant during delivery on 7/10/23 at 12:11 a.m. At delivery, it was determined that the infants head was separated from the torso. The facility failed to provide full disclosure of the condition of the infant to P#1 prior to discharge from the facility on 7/12/23. P#1's deceased infant was picked up from the facility on 7/12/23 by the funeral home. The funeral home notified the county ME's office of the infant's death and condition of the body on 7/13/23.

Cross refer to A-0115 as it relates to the facility's failure to protect and promote Patient's Rights when one (P#1) of five (P#1, P#2, P#3, P#4, P#5) patients reviewed delivered a deceased full-term infant on 7/10/23 at 12:11 a.m. At delivery, it was determined that the infants head was separated from the torso. The facility failed to make full disclosure of the condition of the infant to P#1 prior to discharge from the facility on 7/12/23. The facility's failure to fully disclose the extent of the injury associated with the demised infant resulted in the delay of P#1's participation in post-mortem planning and grievance.

Cross refer to A-0263 as it relates to the facility's failure to ensure that an effective, ongoing, quality assessment and performance improvement program was implemented when one (P#1) of five (P#1, P#2, P#3, P#4, P#5) patients reviewed experienced an adverse event on 7/10/23 at 12:11 a.m. The facility failed to produce a completed external peer review report when requested onsite 8/17/23; by email on 8/18/23; by email 8/29/23; and by email 9/13/23. The report was never received.

Findings included:

Review of the 'Amended and Restated Governing Board Bylaws', reviewed and approved January 2023 revealed in Article II, General Provisions that the facility was owned by the Company. The Company retained all authority and control over the business, policies, operations, and assets of the facility. The Board of Directors delegated its officers to select the CEO or Administrator and appointed the day-to-day business and administration to him/her. The CEO/Administrator reported to the Board of Directors and maintained communication with the Governing Board and Medical Staff.

Continued review revealed that the Medical Staff was accountable to the Governing Board and operated as a part of the facility. Licensed practitioners must be appointed to either the Medical Staff or the AHP Staff and be granted privileges. The Governing Board appointed only those Practitioners that met the qualifications prescribed in the Medical Staff Bylaws and other hospital standards.
A review of 2.3, CEO/Administrator revealed that the Board of Directors delegated broad authority and responsibility including but not limited to:
(a) Carrying out the directives of the Company's officers.
(f) supporting the facility's performance improvement plan and the facility's Patient Safety Program.
(m) Developing criteria utilized to select, employ, evaluate, control, and discharge all employees as authorized by the Governing Board.
(o) Cooperating with the Medical Staff and securing cooperation on the part of those concerned with the rendering of high-quality professional services to all patients. Finding the necessary administrative, fiscal, and personal resources to assist the Medical Staff and departmental/service staff in implementing the facility's Performance Improvement, Risk Management and Safety Programs.
(w) Undertake corrective action for any deficiencies reported by such agencies and prepare documentation of such corrective action, when necessary, to be made available to licensing, accrediting or any governmental agency for the facility's accreditation or plan of correction survey.
2.4 Medical Staff
The organized Medical Staff was established and accountable to the Governing Board and operate as a part of the facility with all independence and self-government rights recognized under law.

A review of the Governing Body meeting minutes for 1/1/22 through 7/31/23 revealed that meetings took place every six months. Standing agenda items included: Administrative Report, Clinical Operations Report, and Performance Improvement/Quality Report. The meeting minutes failed to include a report on the sentinel event that occurred 7/10/23.

A review of the Medical Executive Committee meeting minutes for 2/1/23 through 7/31/23 revealed that meetings were held monthly. Standing agenda items included: Policy and Procedure Review, Credentialing Review, Department and Service Reports, and Administrative Report. The meeting minutes failed to include a report on the sentinel event that occurred 7/10/23.

Review of the facility's policy titled, "Deaths ", effective 10/21/21, last revised 12/9/21, revealed that the purpose of the policy was to establish formal procedures to assure proceedings are handled in accordance with federal, state, and local law, and that notifications, disposition of bodies, and appropriate documentation is performed accurately and in a timely manner.
Further review revealed:
I. In-House Deaths
o Refer to the Emergency Department Death guidelines and contact all consulting physicians and log the disposition of the body in the Body Release Log in the Pathology Department. Questions other than specific funeral home arrangements received from family members of the deceased patient should be directed to the Case Management Department.
II. Management of Coroner's Case
o All suspicious or unusual deaths will be reported ot the Medical Examiner. Notification will be made by the Emergency Department or the unit where the death occurred. Consent is not required; however, the family will be notified that the notification was made.
o The medical examiner must be notified when a death occurs:
A. As a result of violence
B. By casually (accident or disaster).
D. Suddenly - when the individual was in apparent good health; of an individual in apparent good health or when unattended by a physician; in a suspicious or unusual manner, with particular attention to persons under 18 years of age.
G. After birth, but before seven years of age, if the death is unexpected or unexplained.

An interview with the Director of Risk Management (RM) AA took place on 8/17/23 at 11:15 a.m. in the conference room. RM AA recalled that when the funeral home presented to the facility to pick up the infant, the infant could not be released without verification from P#1. The funeral home staff left the facility pending verification from P#1 or family. By this time, Pt#1 had been discharged from the hospital. RM AA further explained that she called the contact number on record for P#1. The contact number was P#1's family member who authorized release of the infant to the funeral home. She further stated that she asked Pt#1's family member to encourage P#1 to follow up with medical doctor (MD) DD. The family member stated that P#1 had an appointment scheduled with the MD. The family member further informed RM AA that the MD only disclosed the infant had sustained bruising and injuries to the neck. P#1's family member responded that she would make sure P#1 keeps her appointment with MD DD. After speaking with Pt#1 family member, RM AA called the funeral director and explained that the family may not know the extent of the injuries to the infant.

RM AA additionally stated that on Thursday, July 13, 2023, the county coroner phoned the facility because the funeral home had contacted their office about the death of the infant. RM AA stated that the family had a private autopsy done and the facility did not have results of that autopsy. RM AA further explained that the Georgia Bureau of Investigation (GBI) was conducting another autopsy that was not complete at that time.
RM AA explained that a 'Death Sheet' is completed in the electronic medical record (EPIC). On this electronic form, if this was a medical examiner case, it would be indicated. RM AA stated that the criteria for when a death would be a Medical Examiner (ME)'s case was on the state website. Per facility's policy titled, "Deaths ", effective 10/21/21, last revised 12/9/21 section II Management of Coroner's Case, letter D. "All suspicious or unusual deaths will be reported to the Medical Examiner and Deaths that occurs .....suddenly - when the individual was in apparent good health". Per facility's medical records, the infant was viable (fetal heart tracing, etc.) and in good standings before the delivery. The infant's death occurred during the delivery process. This should have been reported.

On 8/17/23 at 1:42 p.m. after several attempts to reach P#1 via telephone, a family member of P#1 spoke on behalf of P#1. P#1's family member stated P#1 did not know the depth of the infants' injuries until the funeral home contacted P#1 and the family. P#1's family member recalled that P#1 and family learned of the condition of the body from the funeral home, not the hospital. Immediately after delivery, MD DD informed the family member and P#1's significant other that the infant stopped breathing and lost oxygen which resulted in death. P#1's family member further explained that P#1 and her family were later escorted to see the infant by a member of risk management and a provider. P#1 was told that she was not allowed to pick up the baby because it was hospital policy. P#1 family member went on to state that she was never told what happened. P#1's family member recalled being in the room with P#1 and observing on the monitor that the infant was still alive at 11:37 p.m. and the infant was fine. The infant was delivered at midnight. Further into the interview, P#1 family member recalled that RM AA did contact her to discuss the extent of the infant's injuries, but this was after the funeral home had already informed the family of the condition of the infant's body. The family member recalled that P#1 was discharged by this time.

During a telephone interview with Funeral Director (FD) SS on 8/24/23 at 10:30 a.m., he recalled arriving to the facility to pick up the body of P#1's infant. At the time of this interview, FD SS was not sure of the date and time. He stated that upon arrival, the facility requested that they (funeral home) return in about 45 minutes as the documentation for release of the body was incomplete. He recalled that he received a phone call from someone in risk management who disclosed the condition of the body. FD SS stated that his impression at that time was that the family was unaware of the state of the body. He recalled that the family requested to come to the funeral home and view the body. When the request to view the body by the family was made, he disclosed to the family the condition of the infant's body. FD SS stated that he phoned the Clayton County Coroner's office due to the condition of the body received from the facility. He stated that the coroner's office had no prior knowledge of the baby's death or information pertaining to the condition of the infant's body.

During a telephone interview on 8/29/23 at 4:53 p.m., Medical Examiner (ME) UU said that he became aware of the incident on 7/13/23 around 10:30 a.m. from the funeral home and given some details of the deceased infant. ME UU then contacted the facility and spoke with RM AA to gather more details of the incident and inquire why the facility had not reported the death to the ME office. ME UU recalled that when he spoke with RM AA on 7/13/23, the funeral home was in possession of the body, and he (ME UU) learned that the family hired a personal pathologist to perform an autopsy. ME UU said that once the body was delivered back to the funeral home, the ME's office was able to take jurisdiction and assume responsibility for an autopsy. ME UU recalled calling the Chief ME of the state, who discussed with him (ME UU) that a new autopsy is required. A full autopsy was performed on the morning of 7/15/23.

Based on a review of Medical Staff Bylaws, policies and procedures, medical records and interviews, it was determined that the facility failed to ensure that patient's rights were promoted and protected, and care was received in a safe setting when one (P#1) of five (P#1, P#2, P#3, P#4, and P#5) patients reviewed suffered an infant demise during delivery on 7/10/23 at 12:11 a.m. It was determined at delivery that the infants head was separated from the torso. The facility's failure to follow protocol concerning the notification of patients following an adverse event or outcome resulted in additional distress and pain and inhibited the grieving process for P#1 and family.

Findings included:

Cross refer to A-0144 as it relates to the failure of the facility to ensure that care was received in a safe setting when P#1 suffered an infant demise during delivery on 7/10/23 at 12:11 a.m. At delivery, it was determined that the infants head was separated from the torso.

Review of the facility's 'Medical Staff Bylaws, last approved 10/14/21 revealed in 1.8, unanticipated outcomes, in the event of an unanticipated outcome or adverse event, the patients treating and/or consulting physician participated in discussion of the outcome or event with the patient, family and/or legal representative to the extent appropriate under the hospital's Policy on Disclosure of Treatment Outcomes.

Review of the facility's policy titled, "Patient Rights and Responsibilities ", effective 8/9/22, last
revised on 8/9/22, revealed that the purpose of the policy was to detail the facility's mission to
render personalized care to patients in ways that respect the dignity of each person. Further review revealed that under patient rights:
1. The patient has the right to participate in the development and implementation of his or her
plan of care.
2. The patient or his or her representative (as allowed under State law) has the right to make
informed decisions regarding his or her care. The patients right includes being informed of his or her health status, being involved in care planning and treatment, and being able to request or refuse treatment.
6. The patient has the right to receive care in a safe setting.

Review of the facility's policy titled, "Perinatal - Newborn Loss ", effective 12/31/12, last revised
2/7/17, revealed that the purpose of the policy was to provide comprehensive procedural care
for perinatal/newborn loss. Further review revealed that for the care of perinatal loss greater
than 12 weeks in the Women's Life Center:
C. The family is made aware of options concerning disposition.
D. Nursing staff will not suggest organ donations, offer autopsy, or chromosomal studies.
H. Allow family to see and hold baby.
J. Complete Bereavement Checklist
L. When transferring mother from L&D, baby to remain with the family, if desired. Family will be allowed unlimited visitation during hospitalization unless autopsy is desired.

A review of Patient (P) #1's medical record revealed that P#1 presented to the facility's
Obstetrical Emergency Department (OB-ED) on 7/9/23 at 10:08 a.m. with onset of labor and the infant was delivered on 7/10/23 at 12:11 a.m.

Review of a progress note by MD DD on 7/10/23 at 5:15 a.m., revealed MD DD had gathered all of P#1's family members in a meeting room to confirm and informed them that the infant had expired. Details of the surgery were further discussed with the father of the infant and the patient's aunt. The patient was informed in recovery of the demise of her infant. Several family members were present and at the bedside at this time. It was explained to the family that the infant sustained injuries while the delivery was being attempted.

Review of a clinical note by Certified Nurse Midwife (CNM) EE on 7/10/23 at 5:38 p.m., revealed that the family of P#1 requested to speak with CNM EE. CNM EE was not present at the time of delivery and could not speak on details of the delivery events. During the visit, P#1 began to cry uncontrollably and requested to view the infant. CNM EE explained to the family that P#1's blood pressure was elevated and speaking about the events at this time would not be advised. CNM EE made a request to a RN to facilitate the patient's ability to see the infant.

Review of a progress note by MD DD on 7/11/23 at 7:20 p.m., revealed that MD DD presented to the postpartum (PP) unit with the intention of speaking to P#1 and the family. Further review revealed that after the delivery (7/10/23 at 12:11 a.m.), the baby's father and family of P#1 were briefed on a few events by MD DD, however full details were not disclosed. MD DD also noted that the family requested to speak with the attending physician, however upon MD DD's arrival, the family no longer wanted to speak with MD DD.

A review of a clinical note by Certified Nurse Midwife (CNM) EE on 7/12/23 at 9:04 a.m. revealed that P#1 felt poorly and reported emotional concerns.

A review of P#1's medical record failed to reveal that full disclosure of the condition of the infant's body was made to P#1 or P#1's family.

After reviewing medical records, several interviews were conducted:

During a telephone interview with Physician Assistant (PA) FF on 8/16/23 at 11:15 a.m., he explained that he specialized in psychology and saw P#1 as a consult on 7/10/23 at 5:10 p.m. to assess her coping with loss. PA FF spoke to P#1 with the father of the baby and aunt present. PA FF recalled that P#1 was despondent and did not have much to say. He stated that P#1 appeared to be trying to process the event. He recalled that the family requested grief counseling and resources which he provided.

During a telephone interview on 8/16/23 at 2:57 p.m. with RN LL, she recalled that she assumed care of P#1 on 7/9/23 around 7:00 p.m. (prior to delivery) during shift change. RN LL recalled that P#1 requested a C-section. The charge nurse (CN) explained the criteria for C-Sections to the patient. RN LL stated that the request was relayed to MD DD. RN LL stated that P#1 spoke to RN LL afterwards and asked RN LL if MD DD was going to speak to P#1 about the situation (c-section). RN LL stated that P#1 mentioned that during P#1's prenatal visits, P#1 was told P#1 would have a C-section. RN LL stated that RN LL retrieved P1's prenatal records and did not see what P#1 expressed to RN LL. The baby "came out around 11:00 something when the baby's head came out" The doctor tried to deliver the baby with multiple techniques. P#1 was taken to the OR for an emergency c-section. As P#1 was being transported to the OR, RN LL recalled that she observed the umbilical cord was outside. The fetal heart tones were in the 130's (average fetal heart rate is between 110 and 160 beats per minute). The baby was delivered in the OR. RN LL stated that when P#1 was transferred to the post-partum (PP) unit (unit that cares for women after delivery), P#1's family requested to see the baby. RN LL stated that RN LL was unsure of how to approach the situation given the infant's decapitation and RN LL spoke with multiple Charge Nurses (CN) but none could provide RN LL any guidance and the request was left over to the next shift.

During a telephone interview on 8/17/23 at 9:20 a.m., RN OO recalled that on the first morning (7/10/23) that she cared for P#1, P#1 and the infant's father had been tearful. The provider (Nurse Midwife) saw P#1 during that shift. P#1 asked about seeing her baby. RN OO explained that per the facility's post-operative protocol, patients were to remain on bedrest for the first 12 hours after surgery. P#1 was still on bedrest when RN OO assumed care of her the first morning. Since P#1 remained on bedrest, she would not physically go to the NICU, where the infant was located, to see her infant. RN OO was never informed that the infant could not be brought up to P#1's room, but no staff member would get the infant and bring him to P#1. RN OO stated that she took care of P#1 for two days and the infant was not brought up to the unit either day. P#1, the infant's father, and P#1's family member (aunt) were finally escorted to NICU accompanied by the risk manager and the nurse manager of the unit. RN OO recalled that on the second day after delivery (7/11/23) MD DD, Risk Management, a Nurse Manager, and RN OO were present to attempt to have a meeting with P#1 and P#1's family; however P#1 refused to speak with MD DD. P#1 did speak with the Risk Manager and Nurse Manager. "This was tragic and forever life changing".

An interview with the Director of Risk Management (RM) AA was conducted on 8/17/23 at 11:15 a.m. in the conference room. RM AA was told by staff (unsure) that the infant's father and other family members had viewed the infant the early morning of 7/10/23. RM AA also stated that MD DD had spoken with the infant's father and P#1's aunt about the infant's demise and disclosed that the infant had sustained injuries during delivery.

RM AA stated that MD DD failed to contact anyone in administration after the delivery (7/10/23). Typically, the MD was involved before talking with a patient. RM AA reached out to MD DD office and was informed that MD DD had cancelled her patients and was not in the office. RM AA recalled that MD DD had cases scheduled for Wednesday, July 12, 2023, at the facility. MD DD told P#1's nurse that she (MD DD) would be available to speak with P#1 and her family after her cases were finished. RM AA recalled that P#1 and accompanying family were able to view the infant (unsure of date/time) wrapped in an isolette but were unable to hold the infant. P#1 was discharged 7/12/23.

RM AA also recalled that on 7/12/23 when the funeral home presented to the facility to pick up the baby, the baby could not be released without verification from P#1. RM AA further explained that she called the contact number for P#1 and reached P#1's aunt who authorized release of the infant to the funeral home. RM AA recalled that she asked P#1's aunt to have P#1 follow up with MD DD. P#1's aunt informed RM AA that P#1 had an appointment scheduled for later that day to meet with MD DD. P#1 aunt further informed her (RM AA) that MD DD had only disclosed that the infant had sustained bruising and injuries to the neck during delivery. RM AA recalled that she phoned the funeral director and explained the extent of the injury to the infant. She further explained to the funeral director that the family may not know the full extent of the injuries to the infant.

On 8/17/23 at 1:42 p.m. an attempt to reach P#1 via telephone was unsuccessful, a family member of P#1 spoke on behalf of P#1. She stated that during the hospital stay, after Pt #1 repeatedly requested to see the baby, a member of risk management, provider and nurse manager escorted P#1 and the family to see the infant. P#1's family member recalled that "we" were not allowed to hold the baby because it was against the hospital's policy. She recalled that the provider and RM AA told us we could not pick up the baby. When "everything started to unfold, then we were told it (baby) was stillborn". She stated that the family received a lot of misinformation. She still never told me what happened. "At 11:37 p.m. the baby was fine and delivered at 12 midnight. The funeral home notified us what happened and not the hospital".

During a telephone interview on 8/17/23 at 4:52 p.m., surgical technician (ST) QQ recalled RN LL calling MD DD to inform MD DD that P#1 was requesting a C-Section. ST QQ stated that CN PP spoke with P#1 regarding the criteria for a C-Section. ST QQ stated that P#1 woke up while in recovery and her family told her that the infant was deceased. P#1 requested to see the infant but did not view the infant for reasons unknown to ST QQ. ST QQ recalled that P#1's family member (aunt) and boyfriend were allowed to see the infant. The staff had wrapped the infant in a blanket and placed him in an incubator with injuries concealed.

During a phone interview with Funeral Director (FD) SS on 8/24/23 at 10:30 a.m., he recalled
arriving at the facility to pick up the body of P#1's infant. At the time of the interview, FD SS was not sure of the date and time. He stated that upon arrival, the facility requested that they
(Funeral home) return in about 45 minutes as the documentation for release of the body was
incomplete. He recalled that he received a phone call from someone in risk management from the facility who disclosed the condition of the body. FD SS stated that his impression at that time was that the family was unaware of the state of the body. He recalled that the family requested to come to the funeral home and view the body. When the request to view the body by the family was made, FD SS stated that the family was unaware of the condition of the body, and he (FD SS) made the disclosure to the family.

Based on review of facility policy and procedures, medical record, staff interviews and notes, and logs it was determined that the facility failed to ensure that the patient's right to receive care in a safe setting was protected when one (P#1) of five patients reviewed suffered a demise during delivery on 7/10/23 at 12:11 a.m. At delivery, it was determined that the infants head was separated from the torso.

Findings Included:

A review of the facility's policy titled, "Patient Rights and Responsibilities ", effective 8/9/22, last revised on 8/9/22, revealed that the purpose of the policy was to detail the facility's mission to render personalized care to patients in ways that respect the dignity of each person. Further review revealed that under patient rights:
4. The patient has the right to receive care in a safe setting.

A review of P#1's medical record revealed a history & physical (H&P) by MD DD on 7/9/23 at 12:01 p.m., revealed that P#1 had a past medical history of Diabetes Mellitus (a metabolic condition, involving inappropriately
elevated blood glucose levels) and asthma (a condition which affects your lungs causing
episodes of wheezing or breathlessness) and was on insulin (medication used to control
elevated blood glucose levels). P#1 was 57 inches tall, or 4.7 feet, and weighed 227 pounds (lbs.).

A review of a procedure note by MD DD on 7/10/23 at 5:09 a.m., revealed that prior to this procedure, P#1 was actively pushing while in the Labor and Delivery (L&D) unit and turtling of the neck (having forward head posture where the chin and head stick forward relative to the rest of the body) occurred with the inability to deliver the infant vaginally. MD DD noted that multiple attempts were made to deliver the arm without success, including rotation of the infant, and so a decision was made to take P#1 emergently to the OR. Further review of the procedure note revealed that multiple attempts were made to deliver the infant once P#1 was transferred to the OR bed without success. P#1 was placed under general anesthesia and a C-Section was performed. MD DD noted that a sterile hand was placed to attempt repositioning the head without success, secondary to the infant's head being outside the vagina. Additionally, MD DD noted that there was no indication the infant had any signs of life. MD DD noted delivery of the legs and torso through the hysterotomy (an incision made in the uterus) while the head was delivered vaginally, independent of the body. MD DD noted closure of the C-Section, the surgical repair performed by MD GG, and surgery productive of a non-viable infant.

During a phone interview on 8/16/23 at 2:57 p.m. with RN LL, she recalled that she assumed care of P#1 on 7/9/23 around 7:00 p.m. during shift change. RN LL stated that P#1 was completely dilated around 9:00 p.m., however the baby was not fully descended, and RN LL instructed P#1 to continue with pushing techniques. RN LL recalled that the head of P#1's infant came out of the vagina during the 11:00 p.m. hour with RN LL, MD DD, and a surgical technician (ST) present. MD DD applied a vacuum to P#1's infant's head; however, it was not successful in delivering the infant. RN LL recalled that suprapubic pressure (pressure applied to the lower part of the abdomen) was applied and then an episiotomy (incision made to the vaginal opening) was performed. P#1 was rushed to the OR when these measures were unsuccessful. RN LL recalled seeing the infant's umbilical cord during the transfer to the OR but was not sure if the cord was separated from the infant or prolapsed. RN LL recalled that the time elapsed from the unsuccessful measures until P#1 was taken to the operating room (OR) was less than three minutes. RN LL stated that fetal heart tones (FHT) were noted to be around 130 beats per minute prior to entering the OR. RN LL was not sure of the FHT throughout the procedure as RN LL was occupied with assisting with the procedure. RN LL recalled that MD DD unsuccessfully attempted to deliver the infant vaginally once more after P#1 was in the OR. RN LL stated that eventually, P#1 was put under general anesthesia during which MD DD stated that P#1's infant was deceased and the NICU team left the OR.

During a telephone interview on 8/17/23 at 4:52 p.m. with ST QQ, she explained that the role of
the ST is to assist nursing staff, ensure surgical carts are prepped and ready for use, and to prep
the OR as well. ST QQ recalled that P#1 was transferred onto an OR table within five to ten
minutes of arrival. ST QQ stated that a staff member did have one hand in P#1's vagina to aid
with the infant's head. ST QQ stated that P#1's infant would not come out through the vagina
during this moment. ST QQ recalled that during or just after P#1 was under anesthesia, MD DD attempted to get the infant out the vagina and eventually called a time of death out for the baby. ST QQ recalled seeing the infant's head was starting to rip and eventually it was separated from the body.
.
Review of the facility's Incident Log dated from 5/2/23 to 8/15/23 revealed an incident report was filed on 7/9/23 at 11:54 p.m. pertaining to P#1 in the L&D unit. Further review revealed that P#1 was admitted for a vaginal delivery on 7/9/23 and was called complete around 11:00 p.m. with MD DD present at bedside per the report. After 45 minutes of pushing, MD DD ordered a break. A stat C-Section was called. P#1 was put under general anesthesia, MD DD attempted to reposition the head but was unsuccessful. In the process of delivering, the legs and torso came out separate from the head of the infant. Review of the log failed to reveal a time of death for the infant.

Based on review of the facility's quality assessment performance improvement (QAPI) plan, Medical Staff Bylaws, Governing Body Bylaws, incident report, root cause analysis results, and staff interviews, it was determined that the facility failed to ensure that a timely peer review was completed as a result of a sentinel event when one (P#1) of five (P#1, P#2, P#3, P#4, P#5) patients reviewed experienced an infant demise during delivery on 7/10/23 at 12:11 a.m. During the delivery it was determined that the infant's head had become separated from the torso. The facility failed to produce a completed external peer review report when requested onsite 8/17/23; by email on 8/18/23; by email 8/29/23; and by email 9/13/23. The report was never received.

Findings included:

Cross refer to A-0286 as it relates to the facility's failure to track, analyze, and implement corrective actions in response to adverse patient events.

Cross refer to A-0309 as it relates to the failure of the governing body, medical staff, and administrative staff be accountable to ensure that an ongoing quality improvement and patient safety program was implemented and maintained.

Based on review of facility's quality assessment performance improvement (QAPI) plan, policy and procedures, incident report, root cause analysis results, meeting minutes and staff interviews, it was determined that the facility failed to ensure that the quality assessment performance improvement (QAPI) program analyzed the cause and implemented corrective actions in response to adverse events when one (P#1) of five (P#1, P#2, P#3, P#4, P#5) patients reviewed experienced an infant demise during delivery on 7/10/23 at 12:11 a.m. During the delivery it was determined that the infant's head had become separated from the torso.

Facility staff failed to immediately escalate the incident per the facility's chain of command policy. Facility leadership became aware of the incident on 7/10/23 on or around 8:30 a.m. or approximately eight hours after the event.
The result of a Medical Peer Review was not provided.

Findings included:

Review of the facility's 'Performance Improvement Plan 2023', effective 3/3/23 revealed that the Governing Board had the authority and responsibility for:
-Assured patient safety and quality of patient care and services, including reduction of medical errors through organization-wide mechanisms and policies.
-Systemic evaluation of the effectiveness of the organization-wide performance improvement function.
-Appropriate delegation of adequate resources for measuring, assessing, improving, and sustaining the facility's performance and the reduction of risk to patients.
-Delegation of responsibility for performance improvement functions to the MEC and the Performance Improvement/Risk Management Committee.
The Medical Executive Committee was responsible for:
-Participation in and involvement with activities to improve the quality of care and efficiency of clinical practice patterns.
-Assumed responsibility for setting standards of professional and ethical practices in the peer review process for the medical staff.
-Implementation and maintenance of a systematic review of credentialing and privileges of medical staff members including the use of performance improvement results as appropriate.
-Responsible for the ongoing and focused professional practice evaluation of individual practitioners.
The Performance Improvement (PI) program organized and integrated PI activities into a comprehensive, interdisciplinary program focused on a process of ongoing monitoring and evaluation to facilitate the delivery of the highest quality of patient care and services through:
D. Performance Data, Aggregation and Analysis
g. Intensive Analysis: was performed in order to identify processes to be targeted for change or improvement to reduce or eliminate the possibility of adverse care outcomes or recurrence of similar outcomes. The following require intensive analysis:
Performance measurement reveals significant and undesirable variation from recognized standards.
Never event occurrences (potential and near-misses)
Hazardous conditions
Levels of performance, patterns, or trends that vary significantly and undesirably from those expected for important recently established measures.
Performance measurement reveals significant and undesirable variation from that of similar organizations.
Never Events
A never event was an unexpected occurrence that involved death or serious physical or psychological injury, or the risk of injury thereof. All adverse patient occurrences, which may meet the definition of never event, were reported to the CNO/Administrator and referred to the Chief of Staff and Performance Improvement Director. If the Chief of Staff, in collaboration with the relevant Medical Staff Committees, and Administration determined that a potential never event had occurred, a Root Cause Analysis was completed.

Review of the facility's 'Medical Staff Bylaws, last approved 10/14/21 revealed in
Article VIII-Corrective Actions
8.1(a) Criteria for Initiation
Whenever activities, omissions or any professional conduct are detrimental to patient safety, delivery of quality patient care, are disruptive, undermine the culture of safety, interview with facility operations or violate the provisions of these Bylaws, the Medical Staff Rules and Regulations, or adopted policies and procedures; corrective action against such practitioner may be initiated by any officer of the Medical Staff, the Chairperson of the Department of which the practitioner is a member, by the CEO, or the Board. Procedural guidelines from the Health Care Quality Improvement Act were followed in the event of corrective action against a physician or dentist.
13.1 External Peer Review
The Board of Trustees, the Medical Executive Committee, the Chief of Staff, CEO or Department Chairperson has the authority to request external peer review. Circumstances that may indicate an external review may include, but are not limited to:
-There is no member who qualified as a 'peer', or expertise was lacking.
-Conflicts of interest exists that cannot be appropriately resolved by the MEC or Board.
-Need for opinion from an impartial, expert outsider due to confusing, ambiguous, or conflicting internal review opinion.
-There was potential for medical malpractice suit or significant compliance issue, legal counsel or risk management may recommend external review.
-When a matter has the potential to lead to an action that would require a hearing pursuant to the Health Care Quality Improvement Act of 1986.

Review of the facility's policy titled, "Sentinel Event Policy", last revised 2/1/22, revealed that the purpose of the policy was to address the occurrence of patient safety events in a prompt and efficient manner. Definitions included:
A sentinel event was a patient safety event (not primarily related to the natural course of a patient's illness or underlying condition) that reached a patient and resulted in but not limited to:
-Unanticipated death of a full-term infant
All Sentinel events were reviewed by the facility and subject to review by The joint Commission. An appropriate response included:
-A formalized team response that stabilized the patient, disclosed the event to the patient and family, and provided support for the family and staff involved in the event
-Notification of hospital and corporate leadership including legal
-Immediate investigation
-Completion of a comprehensive systematic analysis for identification of the causal and contributory factors
-Strong corrective actions derived from the causal and contributory factors that eliminated or control systems hazards or vulnerabilities and resulted in sustainable improvement over time
-Time line of implementation of corrective actions
-Systemic improvement

A review of the facility's policy titled 'Administrative Chain of Command', effective 10/5/21 revealed that the purpose was to provide a mechanism for reporting and/or resolving patient, physician, or clinical concerns.
Chain of Command:
Staff Member-
1. Charge Nurse/Immediate Supervisor
2. Department Director
3. Director of Nursing/CNO/Administrator on Call/HR Director
Physician Chain of Command:
1. Attending Physician or designee
2. Chief of Service
3. Chief of Staff
4. Chief Medical Officer (CEO if CMO is unavailable)
Procedures:
Initiating the Chain of Command
1. When a team member is aware of a potential or actual issue, the team member is accountable for:
1.1 Making attempts to prevent or resolve the issue.
1.2 If unresolved, contact their immediate supervisor to alert them of a potential or actual issue.
1.3 If still unresolved, notify the next level of command (i.e. manager/director) during normal business hours or the House Supervisor after business hours.
1.4 If unable to resolve, the House Supervisor contacted the Administrator on Call (AOC)
Initiating Chain of Command for Immediate Patient Care clinical concern
1. Immediate Patient care clinical concern
1.1 Any member of the healthcare team that observes potentially unsafe/sub-optimal care or a failure of a healthcare provider to respond first reports to the charge nurse/area manager.
a. Examples include but are not limited to:
i. A deviation exists between established hospital policy and procedure.
b. If there is a potential immediate threat to the well-being of the patient, the administrative supervisor is contacted who has a list of physician emergency numbers and numbers for MEC. In the absence of a charge nurse, any member of the healthcare team can contact the Administrative Supervisor.
c. If the Administrative Supervisor cannot resolve the issue, the AOC will be notified.
A report must be submitted by the AOC if she is unable to immediately resolve issues regarding credentialed staff.

Review of the facility's Incident Log dated from 5/2/23 to 8/15/23 revealed an incident report was filed on 7/9/23 at 11:54 p.m. pertaining to P#1 in the L&D unit. Further review revealed that P#1 was admitted for a vaginal delivery on 7/9/23 and was called complete around 11:00 p.m. with MD DD present at bedside per the report. After 45 minutes of pushing, MD DD ordered a break. A stat C-Section was called. P#1 was placed under general anesthesia, MD DD attempted to reposition the head but was unsuccessful. In the process of delivering, the legs and torso came out separate from the head of the fetus. Further review revealed that there was no sign of fetus life per MD DD when the C-Section started and the NICU team was present at the time of delivery in the OR.

A review of the facility's document titled 'Root Cause Analysis/Intensive Case Analysis Tool' revealed that the name of the event was fetal demise, shoulder dystocia with trauma and the event occurred on 7/10/23 at 12:11 a.m. The incident was determined to be a sentinel event. The incident was reported via the electronic reporting system and by the labor and delivery Manager. Continued review revealed that the RCA was initiated on 7/10/23. Team meetings were held 7/25/23 and 8/21/23. Team members included the Labor and Delivery Manager, RM AA, CNO BB, EDN CC, the Manager of Mother/Baby and NICU and the Educator. The pertinent conclusion was "Rare tragic complication of shoulder dystocia; will refer to outside Medical Peer Review". Systemic Deficiencies included lack of documentation of the sequence of events by the physician and the staff. Action plan included:
1. Education of sequence of maneuvers during shoulder dystocia and appropriate documentation. Target Date: 9/30/23
2. Shoulder dystocia drill. Target Date: None
3. Fetal monitoring and strip interpretation testing. Target Date: 9/30/23
4. Review documentation of 100% of shoulder dystocia cases for three months until 95% compliance with key documentation is achieved. Begin week of 9/21/23
5. Send case to outside peer review. Target Date: 7/15/23
6. Review Chain of Command in Daily Huddle. Target Date: 8/31/23
7. Education on contacting the medical examiner (fetal death greater than 20 weeks) in daily huddle. Target Date: 8/31/23

The facility failed to provide a completed external peer review report when requested while onsite 8/17/23; by email on 8/18/23; by email 8/29/23; and by email 9/13/23. The report was never received.

Review of the Governing Body meeting minutes for 1/1/22 through 7/31/23 revealed that meetings took place every six months. Standing agenda items included: Administrative Report, Clinical Operations Report, and Performance Improvement/Quality Report. A review of the meeting minutes failed to reveal a discussion of the sentinel event on 7/10/23.

Review of Medical Executive Committee meeting minutes for 2/1/23 through 7/31/23 revealed that meetings were held monthly. Standing agenda items included: Policy and Procedure Review, Credentialing Review, Department and Service Reports, and Administrative Report. A review of the meeting minutes failed to reveal a discussion of the sentinel event on 7/10/23.

Review of the Chief Nursing Officer Report for 1st and 2nd quarter 2023 revealed that Core Measures included but was not limited to:
Unexpected complications of term newborn: 0% for 1st quarter 2023
Patient Safety indicators included:
Birth trauma, injury to neonate 0 incidents for 1st quarter 2023
Obstetric trauma, vaginal delivery without instrumentation 2 incidents for 1st quarter 2023
Obstetric trauma, vaginal delivery with instrumentation 1 incident for 1st quarter 2023

An interview with the Director of Risk Management (RM) AA took place on 8/17/23 at 11:15 a.m. in the conference room. RM AA recalled that she learned of the incident from the labor and delivery manager after the morning huddle on 7/10/23 at around 8:30 a.m. She was informed that the delivery had been at 12:11 a.m. that morning (7/10/23). The night shift staff had already left when RM AA learned of the incident. RM AA explained that the usual chain of reporting when an adverse event occurred was staff reported to charge nurse. The charge nurse reported either to the house supervisor, unit manager, or to Risk Management directly. Risk Management or the Director of Nursing informed the CEO. If the event involved a physician, the Chief Medical Officer was notified.
RM AA recalled that the first step taken after learning of the incident was to notify the chief executive officer. RM AA explained that MD DD was a private physician that had privileges at the facility and that there was no 'chain of command'. She stated that the Chair of Obstetrics was in practice at MD DD's private office and was excluded from the peer review process. The facility had sent the case to an external peer reviewer and had already received the report.

During an interview on 8/17/23 at 12:05 p.m. in the conference room, CNO BB stated that she was not involved with any staff member during the time of the incident as she was on leave. CNO BB stated that if an incident occurs, nursing staff are to complete a report and inform management as soon as possible.

During an interview on 8/17/23 at 2:37 p.m. in the conference room Charge Nurse (CN) PP recalled that when he saw P#1, her infant was out of the vagina and staff members attempted to support the head. CN PP explained that he did not know if P#1's infant was alive or not when P#1 went to the OR. CN PP recalled that P#1 was losing a lot of blood and CN PP prepped P#1 for the C-Section. CN PP left prior to the delivery of the infant as CN PP had to round on the rest of the patients on the unit and check on other staff members. CN PP stated that an incident report was completed.

During a phone interview with the Chair of Obstetrics, MD MM on 8/17/23 at 4:00 p.m., she explained that she was employed by MD DD in her private office and referred to MD DD as 'her boss'. MD MM stated that she had not reviewed P#1's medical record. The interview was concluded at that time.
During an interview on 8/17/23 at 4:30 p.m. in the conference room with CEO RR recalled that she was informed of the incident the morning of 7/10/23 after an administration meeting. CEO RR explained that due to a conflict of interest, the incident was reviewed by external peer reviewers. CEO RR stated that MD DD was in an inactive status currently.

During a telephone interview on 8/17/23 at 4:52 p.m. with ST QQ, she explained that the role of the ST is to assist nursing staff, ensure surgical carts are prepped and ready for use, and to prep the OR as well. ST QQ recalled RN LL calling MD DD to inform MD DD that P#1 was requesting a C-Section. ST QQ stated that the House Coordinator was aware of the incident. ST QQ stated that no one had interviewed her about the events.

During a follow up interview with RM AA in the conference room on 8/17/23 at 5:20 p.m., she explained that the facility's investigation was ongoing and per the facility policy, it had to be completed within 45 days. She further explained that all interviews and reviews had been conducted and the last step was to write up the investigation. She stated that the root cause analysis looks at the processes. RM AA verified that all staff involved during the incident had been interviewed by either herself or their manager. She stated that members of the medical staff not employed by the facility were not required to be interviewed, their interviews were voluntary.

MD DD failed to respond to interview requests during the onsite investigation.

Based on review of the facility's root cause analysis results, Medical Staff Bylaws, and staff interviews, it was determined that the Governing Body, medical staff, and administration failed to ensure that an ongoing program for quality improvement and patient safety was implemented and maintained when it was determined that a peer review report was not available in response to a sentinel event that occurred 7/10/23.

Findings included:

A review of the facility's document titled 'Root Cause Analysis/Intensive Case Analysis Tool' revealed that the name of the event was fetal demise, shoulder dystocia with trauma and the event occurred on 7/10/23 at 12:11 a.m. Continued review revealed that the RCA was initiated on 7/10/23. The pertinent conclusion was "Rare tragic complication of shoulder dystocia; will refer to outside Medical Peer Review". Systemic Deficiencies included lack of documentation of the sequence of events by the physician and the staff. Action plan included:
Send case to outside peer review. Target Date: 7/15/23
Review Chain of Command in Daily Huddle. Target Date: 8/31/23

Review of the facility's 'Medical Staff Bylaws, last approved 10/14/21 revealed in
Article VIII-Corrective Actions
8.1(a) Criteria for Initiation
Whenever activities, omissions or any professional conduct are detrimental to patient safety, delivery of quality patient care, are disruptive, undermine the culture of safety, interview with facility operations or violate the provisions of these Bylaws, the Medical Staff Rules and Regulations, or adopted policies and procedures; corrective action against such practitioner may be initiated by any officer of the Medical Staff, the Chairperson of the Department of which the practitioner is a member, by the CEO, or the Board. Procedural guidelines from the Health Care Quality Improvement Act were followed in the event of corrective action against a physician or dentist.
13.1 External Peer Review
The Board of Trustees, the Medical Executive Committee, the Chief of Staff, CEO or Department Chairperson has the authority to request external peer review. Circumstances that may indicate an external review may include, but are not limited to:
-There is no member who qualified as a 'peer', or expertise was lacking.
-Conflicts of interest exists that cannot be appropriately resolved by the MEC or Board.
-Need for opinion from an impartial, expert outsider due to confusing, ambiguous, or conflicting internal review opinion.
-There was potential for medical malpractice suit or significant compliance issue, legal counsel or risk management may recommend external review.
-When a matter has the potential to lead to an action that would require a hearing pursuant to the Health Care Quality Improvement Act of 1986.

An interview with the Director of Risk Management (RM) AA took place on 8/17/23 at 11:15 a.m. in the conference room. RM AA explained that MD DD was a private physician that had privileges at the facility and that there was no 'chain of command'. She stated that the Chair of Obstetrics was in private practice at MD DD's private office and was excluded from the peer review process. The facility had sent the case to an external peer reviewer and had received the report already. RM AA explained that MD DD had been asked to take a voluntary leave of absence. MD DD cannot schedule cases or take call at this time. She further explained that the term 'active' pertaining to credentialing indicated the volume of patients that physicians admitted to the facility.

During an interview on 8/17/23 at 4:30 p.m. in the conference room with Chief Executive Officer (CEO) RR, she recalled that she was informed of the incident the morning of 7/10/23 after an administration meeting. CEO RR stated that the administration reviewed fetal strips, documentation, and reached out to a counselor to help with staff therapy. CEO RR contacted MD DD to learn more about the incident and asked MD DD to take a voluntary restriction from exercising privileges. CEO RR explained that if MD DD declined to take voluntary leave, she (CEO RR) would have to exercise facility bylaws. CEO RR followed up with Risk Management and MD DD to aid in getting disclosure to P#1 and P#1's family. CEO RR explained that the incident was reviewed by external peer reviewers because of conflict of interest with the facility staff. CEO RR stated that MD DD is in an inactive standing as of current. CEO RR believed that the facility followed appropriate procedures and bylaws following the incident.

During a phone interview with the Chair of Obstetrics, MD MM on 8/17/23 at 4:00 p.m., she explained that she was employed by MD DD in her private office and referred to MD DD as 'her boss'. MD MM stated that she had not reviewed P#1's medical record. The interview was concluded at that time.

MD DD failed to respond to interview requests during the onsite investigation.